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Meet Irene, Senior Regulatory
Affairs Consultant

Irene, standing in a grey sweater over a white collared shirt, smiling at the camera

As a Senior Regulatory Affairs Consultant of Parexel's Functional Service Provider (FSP) department, Irene's approach and scientific expertise are vital in bringing life-changing treatments to patients. From writing precise labelling claims to navigating complex regulatory landscapes, discover how Irene's commitment to putting patients first is shaping the future of healthcare one document at a time.

What does a day in the life of your role look like?

A day in the life of a Regulatory Affairs Consultant is dynamic and multifaceted. It involves crafting precise labelling claims, delving into complex supporting data, and conducting thorough analyses of competitors' labels. Collaboration is key, with frequent interactions with stakeholders involved in label writing and close cooperation with the Labelling team. These daily activities not only contribute to the development of critical regulatory documents but also foster an environment of continuous learning and process improvement. Each day brings new challenges and opportunities to apply expertise in ensuring that life-changing treatments reach patients safely and effectively.

What unique blend of skills makes a Regulatory Affairs Consultant thrive on your team?

Successful Regulatory Affairs Consultants on Parexel's FSP team possess a unique blend of skills. The role demands meticulous attention to detail, coupled with a strong sense of due diligence and scientific curiosity. Creative problem-solving and the ability to think outside the box are essential for navigating complex regulatory landscapes. Additionally, effective project planning and a deep understanding of regulatory frameworks form the foundation of their expertise. Strong communication skills and diplomacy are crucial for collaborating with global teams and stakeholders. 

What's been your most exhilarating project triumph, and how did you achieve it?

I recently managed the update of multiple documents at the same time, having to deal with two different teams (one being new for me), topics of different nature (safety/technical), and a new process. I was able to complete all the tasks successfully, on time and with high quality.

Making a Difference Through Clinical Research

What elements of your work at Parexel fuel your enthusiasm and drive?

My job as Labelling Lead allows me to be creative, while also being connected to science at the same time. Within my role and team, I appreciate the effective communication, attention to details, and really keeping patients "at the heart of what I do".

What motivated you to pursue a career at Parexel?

After 11 years in the pharmaceutical company, I decided to step out of my comfort zone and give myself an opportunity to grow and learn new things. I also wanted to join a company that valued my expertise and professionality.

How do you work 'With Heart' and what does it mean to you?

Working 'With Heart' means that I put people at the center of my daily life. I ensure to never forget that anyone from patients, friends and family to colleagues could be impacted by my job.

How does Parexel's patient-centric approach influence your work and motivation?

It is absolutely crucial. Our job in the pharmaceutical industry cannot forget that patients are the ultimate beneficiaries of what we do every day, irrespective of our roles.

How do you embody Parexel's 'Winning as one Team' spirit in your daily work?

Working on the Functional Service Provider (FSP) side, I bring Parexel behaviors in all the activities I perform for my client. I strive to get the job done right first time and I feel accountable for my projects, never giving up until the job is done and done well. I have a very good relationship with my team, I know I can count on them, and they can count on me.

What makes Parexel stand out in fostering personal and professional growth?

At Parexel, personal development is highly encouraged, supported and facilitated by the large availability of courses, networking opportunities, communities of interest, mentoring programs, etc. Within the first few months at Parexel, I was given the opportunity to attend the Fast Start course, which led to having a very great relationship with my manager. It enabled me to focus on priorities for my development, targeting both the personal/professional growth and getting acquainted with the company.

Beyond the Job Title

How does Parexel support flexibility and work-life balance?

I am a fully remote worker and I generally work from home; however, I have been allowed to work from other places than home, to avoid full isolation. I can manage my daily working time in a very flexible manner, this ensures a very good work-life balance.

Rotating images of Irene and her photography of Italy landscapes.

Are there any habits, behaviors, or beliefs you find to be helpful in your everyday activities?

I respect and value people, as the human relationships are the true value in life. I nurture my emotional intelligence and leave room for smiles and irony. I am curious and want to keep learning and developing myself. I pay attention to details in everything I do and adhere to what I commit to.

What do you enjoy outside of work?

I enjoy spending time with my adored family. I love travelling with my son, photography, reading, amusement parks (especially roller coasters), going to cinema and Zumba dancing!

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